Senior Biostat Programmer
Woodcliff Lake, NJ
At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization for the position of Senior Biostat Programmer. You will support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate and QC outputs; and ensure timely and accurate programming and validation activities for clinical studies and publications. This 12-month position is located in Woodcliff Lake, New Jersey.
- Providing statistical programming and validation support for clinical study reports, and publications Overseeing programming activities by external vendors (e.g., CROs)
- Work with the clinical study team on study design, development and review of clinical study protocols
- Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed
- Work with the project statistician and clinical data managers on design and review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT)
- Generate or review data tables and listings and coordinate data review meetings during the course of the study to ensure data quality
- Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management
- Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents
- Work independently to accomplish tasks and goals defined by supervisor and bringing in new ideas to improve the programming process and maintaining standards for programming activities
- Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables
- A minimum of 5 years of experience in the pharmaceutical, CRO or biotech industry
- Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH
- Strong CDISC data standards, e.g. SDTM and ADaM
- Good technical writing skills
- Proven experience with UNIX and Windows operating systems
- Understanding of the software development life cycle
- Understanding of FDA guidelines
- Master’s Degree in Biostatistics and Statistics preferred
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.